The 12-month results from the 1,038-patient SOURCE Registry revealed a 72.1% survival rate for patients who had the valve implanted transapically versus 81.1% for those who had the valve implanted using the femoral artery, said Martyn Thomas, MD, of Kings College Hospital in London. Thomas reported the results during a late-breaking trials session at EuroPCR.

Indeed, the 12-month mortality rate observed among transapical patients in the SOURCE registry were better than the TA data from previous registries, as Thomas illustrated by comparing them to pooled 12-month data from REVIVE, REVIVAL, TRAVERCE, and PARTNER EU registries. The pooled data revealed a 12-month survival rate of 58% for transapical patients and 75% for transfemoral patients.

At a press conference, Thomas said that the comparison demonstrated that the survival for TA patients was clearly improving, most likely due to better patient selection and more experienced operators.

The registry includes outcomes data from 100% of patients treated with the valve from November 2007 through January 2009. Thomas reported the 12-month results from cohort 1, and 30-day results from an additional 1,301 patients in cohort 2.

Asked to explain the need for two cohorts in a registry trial, Thomas said that "one of the problems with registries is that as data are reported, the denominator keeps changing. We decided to stop the cohort at a specific number -- 1,038 -- so that all future reports on this cohort will use the same denominator, and thus be easier to interpret. The same is true of cohort 2, which was stopped at 1,301."

The report here was seen as a "win" for Edwards Lifesciences, which is developing the valve, and is considered a harbinger of what many now expect to be positive results from a pivotal randomized trial of the device. The results from that randomized study, the PARTNER trial, are expected to be reported in September, and those are the results that will go to the FDA when the company seeks approval of the device.

Thomas told MedPage Today that he was particularly encouraged because the pattern of mortality with the TA approach was similar to that seen with TF patients. As with the transfemoral patients, the greater mortality risk was seen at 12 months, not 30 days.

"There is a dropoff, an increased mortality at one year with both TA and TF, and the dropoff, if you will, is pretty much what is expected with 80-year-old, frail patients," he said.

At the same time, he said 19 patients had strokes between 30 days and 12 months, including 13 ischemic strokes. He didn't speculate as to the cause, but said this was a signal that would require additional evaluation.

Typically, patients who undergo transapical procedures are older and frailer -- and thus higher-risk -- than the TF patients. Thomas urged that the results be interpreted in light of the fundamental difference between the two groups -- at baseline the average euroSCORE, which is a measure of risk, was 32.5% in the TA patients versus 25.5% in the TF patients. Patients who underwent transapical procedures were also more likely to have renal dysfunction, a history of CABG, mitral valve disease, and total calcification (porcelain) of the aorta.

Thirty-day survival for all patients was 91.2%; for the TA patients it was 89.2% versus 93.7% for TF patients.

About a quarter of all deaths over the 12 months were classified as cardiac and 49% were considered noncardiac, including deaths classified as pulmonary, renal failure, or cancer. Another 26% of deaths, including 18 sudden deaths, were classified as unknown. Thomas said classifying the deaths was one of the more daunting aspects of the study because the average age of the patients was 82 and many were discovered dead in their own beds.

The SOURCE Registry is supported by Edwards Lifesciences, which is developing the Sapien valve.

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